BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2961735 · Received January 14, 2013

    Report

    Report Number
    1218950-2013-00176
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Report Date
    December 27, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PHILIPS FIELD SERVICE ENGINEER EVALUATED THE DEVICE AND VERIFIED THE FAILURE. THE ISSUE WAS DETERMINED TO BE A MALFUNCTION OF THE POWER PCA. THE POWER PCA WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE PASSED ALL TESTING AND REMAINED AT THE CUSTOMER'S SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WAS NOT BOOTING UP. NO ADVERSE PT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21494 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1